Sealing and encapsulation in energized ophthalmic devices with annular inserts

ABSTRACT

This invention discloses methods and apparatus for sealing and encapsulating Components on and within an annular Multi-Piece Insert. In some embodiments, an ophthalmic Lens is cast molded from a silicone hydrogel, and the Component includes a sealed and encapsulated Multi-Piece Insert portion.

FIELD OF USE

This invention describes methods, apparatus, and devices related tosealing and encapsulation aspects related to ophthalmic devices and,more specifically, in some embodiments, the sealing and encapsulationaspects in the fabrication of an ophthalmic Lens with a Multi-PieceInsert within which or upon which are Components.

BACKGROUND

Traditionally, an ophthalmic device, such as a contact Lens, anintraocular Lens, or a punctal plug included a biocompatible device witha corrective, cosmetic, or therapeutic quality. A contact Lens, forexample, can provide one or more of vision-correcting functionality,cosmetic enhancement, and therapeutic effects. The physicalcharacteristics of the Lens provide each function. A designincorporating a refractive quality into a Lens can provide avision-corrective function. A pigment incorporated into the Lens canprovide a cosmetic enhancement. An active agent incorporated into a Lenscan provide a therapeutic functionality. Such physical characteristicsmay be accomplished without the Lens entering into an Energized state.

More recently, active Components have been incorporated into a contactLens. Some Components can include semiconductor devices. Some exampleshave shown semiconductor devices embedded in a contact Lens placed uponanimal eyes. However, such devices lack a freestanding energizingmechanism. Although wires may extend from a Lens to a battery to powersuch semiconductor devices and it has been theorized that the devicesmay be wirelessly powered, no mechanism for such wireless power has beenavailable.

It is desirable therefore to have additional methods and apparatusconducive to the formation of ophthalmic Lenses that are Energized to anextent suitable for providing one or more functionality into anophthalmic Lens and controlling change in optical characteristic of anophthalmic Lens or other biomedical device. In the process offabricating such ophthalmic and biomedical devices, there may benumerous Components where the nature of the Components' physical andchemical isolation, or lack thereof, may be important. Novel methods,devices, and apparatus relating to the sealing and encapsulation ofvarious Components in Energized ophthalmic and biomedical devices aretherefore important.

SUMMARY

Accordingly, the present invention includes innovations relating to thesealing and encapsulation of various Components including, for example,inserts that can be Energized and incorporated into an ophthalmicdevice. Examples of such ophthalmic devices may include, for example, acontact Lens or a punctal plug. From a more general perspective,numerous other Energized biomedical devices may be relevant within thescope of the invention. In addition, methods and apparatus for formingan ophthalmic Lens with a sealed or encapsulated Multi-Piece Insert arepresented. In some embodiments, the media in an Energized state iscapable of powering a Component capable of drawing a current. Componentsmay include, but are not limited to, a variable optic Lens element, asemiconductor device, and an active or passive electronic device. TheseComponents may also include the ability to be activated by an externalsignal of various types. Some embodiments can also include a cast-moldedsilicone hydrogel contact Lens with a rigid or formable Energized insertcontained within the ophthalmic Lens in a biocompatible fashion.

The present invention therefore includes methods for the formation of aninsert by sealing at least a Front Curve Piece and a Back Curve Piecetogether. The method may include steps for defining electricalinterconnects and attaching devices to the interconnects and/or to thecurve pieces. The devices that result from the processing using thesemethods are also included.

In some alternative embodiments, there may be a second Back Curve Piecethat is added to the previously mentioned two-piece insert. In thesecases, the sealing of the various pieces may create multiple cavities.The method steps to include additional discrete pieces to inserts eitherin sequential processing or in parallel processing steps are consistentwith the nature of the inventive art herein.

In some embodiments, inserts may contain electrical Components. Some orall of these Components may be included in the space that is internal tosealed cavities within the insert. Other embodiments may result from theplacement of the electrical Components in a location that is exterior tothe formed cavities. In embodiments with exterior Components, it may beuseful to encapsulate the Components in their own encapsulatingmaterial.

The cavities that are formed by the various embodiments may also containfluids of various kinds. For example, in a liquid meniscus-typeembodiment, a central cavity located at least in part in an Optical Zoneof an ophthalmic insert may contain liquids related to the formation ofLenses. In some embodiments, the liquid may be placed within the regionthat defines the cavity before or during the sealing process thatdefines the cavity. In other cases, the liquid may be added after theformation of a sealed cavity, for example, by injection of fillingneedles through one or more regions in either a Back Curve Piece orFront Curve Piece followed by the subsequent sealing of the resultingpenetration in the Back Curve Piece or Front Curve Piece.

The methods of forming seals and the resulting sealing devices areimportant aspects of various embodiments. In some embodiments, the sealsmay include preformed materials that are formed into shapes consistentwith the subsequent formation of sealed regions. In other embodiments,seals may be formed in place by the application of sealing agents upon asurface of one or both of the Back Curve Piece and Front Curve Pieces.In some of these embodiments, the applied sealing agent may be allowedto cure before the assembly of multiple pieces; in other cases, theuncured sealing material will be further processed to assemble multiplepieces.

In embodiments with either pre-cured sealing materials or uncuredsealing materials, the two pieces that are sealed with these materialsto each other may be held in place or pressed together to form the seal.In some embodiments, the surfaces that are pressed together to form aphysical contact for the seal may be subsequently held in place by theplacement of an adhesive material spanning the two pieces, which, aftercuring, permanently affixes the two surfaces in place and maintains thesealing aspect of the seal material between the two pieces.

In some alternative embodiments, the surfaces that are pressed togethermay activate a self-sealing mechanism. The self-sealing mechanism maylock or self-lock the two or more pieces together and maintain pressureon the sealing material, which in turn maintains the physical contact toform the seal integrity. Other mechanisms may include additionalfeatures in the sealing region such as, for example, grooves for theplacement of sealing material and knife-edges in the surface topographyto better enhance the performance of the sealing region.

The features that are attached upon either or both of the Front CurvePiece and Back Curve Piece may also have embodiments relating to theirsealing or encapsulating. The conductive traces, energization elements,and/or the electronic Components may have sealing or encapsulatingmaterial deposited in such a manner to span the entire trace,energization element, or Component, therefore allowing for contactbetween the encapsulating and sealing material on either end and eitheror both of the Front Curve Piece or Back Curve Piece material.

The resulting Multi-Piece Insert devices may be further processed toform ophthalmic devices and novel methods relating to the methods ofthese ophthalmic device formation. In some embodiments, an insert may beplaced within a first Mold part where a small amount of Lens bodyforming material may be found. In other embodiments, this Lens-FormingMixture may include, for example, hydrogel-forming materials. AdditionalLens-Forming Mixture may be added before, during, or after a second Moldpart is moved into proximity to the first Mold part. The movement of thesecond Mold part in proximity to the first Mold part may form a cavityin which the insert and Lens-Forming Mixture may be molded into acomposite Lens with high quality optical surfaces. The insert that isembedded in this resulting ophthalmic device may have encapsulatedComponents and/or Components that reside in sealed regions.Additionally, the molded Lens-Forming Mixture, which in some embodimentsmay surround the insert, may be considered an insert-encapsulatinglayer. The Components within or upon the insert may include electronictraces, energization devices, electronic devices including, for example,integrated circuits, and active optic elements including, for example,liquid meniscus Lenses.

DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates exemplary Mold assembly apparatus components that maybe useful in implementing some embodiments of the present invention.

FIG. 2 illustrates an exemplary Energized ophthalmic Lens with aMulti-Piece Insert embodiment.

FIG. 3 illustrates a cross-sectional representation of an exemplarysealing embodiment for a Multi-Piece Insert.

FIG. 4A illustrates a top down representation of an exemplary two-pieceinsert embodiment of a Multi-Piece Insert.

FIG. 4B illustrates a cross-sectional representation of an exemplarytwo-piece insert embodiment of a Multi-Piece Insert.

FIG. 5 illustrates an alternative embodiment of the Multi-Piece Insertsealing region of the exemplary device in FIG. 4B.

FIG. 6 illustrates an alternative embodiment of the Multi-Piece Insertsealing region of the exemplary device in FIG. 4B.

FIG. 7 illustrates an alternative embodiment of the sealing region inthe exemplary device in FIG. 3.

FIG. 8 illustrates an alternative embodiment of the sealing region inthe exemplary device in FIG. 3.

FIG. 9 illustrates an alternative embodiment of the sealing region inthe exemplary device in FIG. 3.

FIG. 10 illustrates method steps for forming an Energized ophthalmicLens with a sealed and encapsulated Multi-Piece Insert according to someembodiments of the present invention.

FIG. 11 illustrates an example of apparatus components for placing asealed insert into an ophthalmic Lens Mold part.

FIG. 12 illustrates a processor that may be used to implement someembodiments of the present invention.

FIG. 13A illustrates a top down representation of an exemplary two-pieceannular insert embodiment of a Multi-Piece Insert.

FIG. 13B illustrates a cross-sectional representation of an exemplarytwo-piece annular insert embodiment of a Multi-Piece Insert.

FIG. 14 illustrates an exemplary three-piece annular insert embodimentof a Multi-Piece Insert.

FIG. 15 illustrates exemplary method steps for forming an annularMulti-Piece Insert.

DETAILED DESCRIPTION OF THE INVENTION

The present invention includes methods and apparatus for manufacturingan ophthalmic Lens with a Multi-Piece Insert where portions of theinsert and Components comprising the insert may include aspects ofsealing and encapsulation. In addition, the present invention includesan ophthalmic Lens with a Multi-Piece Insert incorporated into theophthalmic Lens including the aspects of sealing and encapsulation.

According to the present invention, an Energized Lens is formed with anembedded insert and an Energy Source, such as an electrochemical cell orbattery as the storage means for the Energy. In some embodiments, thematerials comprising the Energy Source are encapsulated and isolatedfrom an environment into which an ophthalmic Lens is placed.

In some embodiments, a Multi-Piece Insert also includes a pattern ofcircuitry, Components, and Energy Sources. Various embodiments mayinclude the Multi-Piece Insert locating the pattern of circuitry,Components, and Energy Sources around a periphery of an Optical Zonethrough which a wearer of a Lens would see. Other embodiments mayinclude a pattern of circuitry, Components, and Energy Sources that aresmall enough to not adversely affect the sight of a contact Lens wearer,and therefore the Multi-Piece Insert can locate them within, or exteriorto, an Optical Zone.

In general, according to some embodiments of the present invention, aMulti-Piece Insert is integrated into an ophthalmic Lens via automationthat places an Energy Source in a desired location relative to a Moldpart used to fashion the Lens. The embodiments that place the variousComponents into the ophthalmic Lens may employ one or more steps whereComponents are sealed and adhered into place or where Components areencapsulated.

In some embodiments, an Energy Source is placed in electricalcommunication with a Component that can be activated on command anddraws electrical current from the Energy Source included within theophthalmic Lens. A Component may include, but is not limited to, asemiconductor device, an active or passive electrical device, or anelectrically activated machine, including, for example,microelectromechanical systems (MEMS), nanoelectromechanical systems(NEMS), or micromachines. Subsequent to placing the Energy Source andComponent, the Mold part can shape and polymerize a Reactive Mixture toform the ophthalmic Lens.

In the following sections, detailed descriptions of embodiments of theinvention will be given. The description of both preferred andalternative embodiments are exemplary embodiments only, and it isunderstood that to those skilled in the art that variations,modifications, and alterations may be apparent. It is therefore to beunderstood that said exemplary embodiments do not limit the scope of theunderlying invention.

GLOSSARY

In this description and claims directed to the presented invention,various terms may be used for which the following definitions willapply:

Back Curve Piece: as used herein refers to a solid element of aMulti-Piece Insert that, when assembled into the said insert, willoccupy a location on the side of the Lens that is on the back. In anophthalmic device, said piece would be located on the side of the insertthat would be closer to the wearer's eye surface. In some embodiments,the Back Curve Piece may contain and include a region in the center ofan ophthalmic device through which light may proceed into the wearer'seye. This region may be called an Optical Zone. In other embodiments,the piece may take an annular shape where it does not contain or includesome or all of the regions in an Optical Zone. In some embodiments of anophthalmic insert, there may be multiple Back Curve Pieces, and one ofthem may include the Optical Zone, while others may be annular orportions of an annulus.

Component: as used herein refers to a device capable of drawingelectrical current from an Energy Source to perform one or more of achange of logical state or physical state.

Encapsulate: as used herein refers to creating a barrier to separate anentity, such as, for example, a Multi-piece Insert, from an environmentadjacent to the entity.

Energized: as used herein refers to the state of being able to supplyelectrical current to or to have electrical Energy stored within.

Energy: as used herein refers to the capacity of a physical system to dowork. Many uses within this invention may relate to the said capacitybeing able to perform electrical actions in doing work.

Energy Source: as used herein refers to a device capable of supplyingEnergy or placing a biomedical device in an Energized state.

Energy Harvesters: as used herein refers to device capable of extractingEnergy from the environment and convert it to electrical Energy.

Front Curve Piece: as used herein refers to a solid element of aMulti-Piece Insert that, when assembled into the said insert, willoccupy a location on the side of the Lens that is on the front. In anophthalmic device, said piece would be located on the side of the insertthat would be further from the wearer's eye surface. In someembodiments, the piece may contain and include a region in the center ofan ophthalmic device through which light may proceed into the wearer'seye. This region may be called an Optical Zone. In other embodiments,the piece may take an annular shape where it does not contain or includesome or all of the regions in an Optical Zone. In some embodiments of anophthalmic insert, there may be multiple Front Curve Pieces, and one ofthem may include the Optical Zone, while others may be annular orportions of an annulus.

Lens: as used herein refers to any ophthalmic device that resides in oron the eye. These devices can provide optical correction or may becosmetic. For example, the term Lens can refer to a contact Lens,intraocular Lens, overlay Lens, ocular insert, optical insert, or othersimilar device through which vision is corrected or modified, or throughwhich eye physiology is cosmetically enhanced (changing appearance ofiris color) without impeding vision. In some embodiments, the preferredLenses of the invention are soft contact Lenses and made from siliconeelastomers or hydrogels.

Lens-Forming Mixture or Reactive Mixture or Reactive Monomer Mixture(RMM): as used herein refers to a monomer or prepolymer material thatcan be cured and crosslinked or crosslinked to form an ophthalmic Lens.Various embodiments can include Lens-Forming Mixtures with one or moreadditives such as, for example, UV blockers, tints, photoinitiators orcatalysts, and other additives useful in ophthalmic Lenses such ascontact or intraocular Lenses.

Lens-Forming Surface: as used herein refers to a surface that is used tomold a Lens. In some embodiments, any such surface can have an opticalquality surface finish, which indicates that it is sufficiently smoothand formed so that a Lens surface fashioned by the polymerization of aLens forming material in contact with the molding surface is opticallyacceptable. Further, in some embodiments, the Lens-Forming Surface canhave a geometry that is necessary to impart to the Lens surface thedesired optical characteristics, including without limitation,spherical, aspherical and cylinder power, wave front aberrationcorrection, corneal topography correction, or combinations thereof.

Lithium Ion Cell: as used herein refers to an electrochemical cell wherelithium ions move through the cell to generate electrical Energy. Thiselectrochemical cell, typically called a battery, may be Reenergized orrecharged in its typical forms.

Multi-Piece Insert: as used herein refers to a formable or rigidsubstrate capable of supporting an Energy Source within an ophthalmicLens. In some embodiments, the Multi-Piece Insert also supports one ormore Components.

Mold: as used herein refers to a rigid or semi-rigid object that may beused to form Lenses from uncured formulations. Some preferred Moldsinclude two Mold parts forming a front curve Mold part and a back curveMold part.

Optical Zone: as used herein refers to an area of an ophthalmic Lensthrough which a wearer of the ophthalmic Lens sees.

Power: as used herein refers to work done or energy transferred per unitof time.

Rechargeable or Reenergizable: as used herein refers to a capability ofbeing restored to a state with higher capacity to do work. Many useswithin this invention may relate to the capability of being restored toa state with the ability to flow electrical current at a certain ratefor a certain, reestablished time period.

Recharge or Reenergize: as used herein refers to an act of restoring toa state with higher capacity to do work. Many uses within this inventionmay relate to restoring a device to a state with the capability to flowelectrical current at a certain rate for a certain, reestablished timeperiod.

Released from a Mold: as used herein refers to an act where a Lens iseither completely separated from the Mold or is only loosely attached sothat it can be removed with mild agitation or pushed off with a swab.

Stacked Integrated Component Devices (SIC-Devices): as used hereinrefers to the product of packaging technologies that can assemble thinlayers of substrates, which may contain electrical and electromechanicaldevices, into operative integrated devices by means of stacking at leasta portion of each layer upon each other. The layers may compriseComponent devices of various types, materials, shapes, and sizes.Furthermore, the layers may be made of various device-productiontechnologies to fit and assume various contours.

Ophthalmic Lenses

Proceeding to FIG. 1, an apparatus 100 to form ophthalmic devicescontaining sealed and encapsulated inserts is depicted. The apparatusincludes an exemplary front curve Mold 102 and a matching back curveMold 101. An insert 104 and a body 103 of the ophthalmic device may belocated inside the front curve Mold 102 and the back curve Mold 101. Insome embodiments, the material of the body 103 may be a hydrogelmaterial, and the insert 104 may be surrounded on all surfaces by thismaterial.

The insert 104 may be one of many different types of inserts. In FIG. 1,there may be at least one sealed surface 105 in the insert 104. Otherembodiments may include different types of seals and encapsulations,some of which are discussed in later sections. The use of the apparatus100 may create a novel ophthalmic device comprised of a combination ofComponents with numerous sealed regions.

Proceeding to FIG. 2, an exemplary embodiment 200 of said novelophthalmic device is depicted in cross section. An ophthalmic deviceshell 230 may surround the embodiment 200. The shell 230 may be formedby the Mold embodiment 100 depicted in FIG. 1 and may be comprised ofnumerous materials, including, for example, hydrogel compounds.

This embodiment 200 may also include an insert 240. In some embodiments,the insert 240 may be comprised of multiple pieces, and it may utilizeseals of various kinds to assemble the insert 240.

This embodiment 200 may include a Component device layer 210 that mayinclude, for example, activation elements, processing elements,energization elements, and sensing elements. Numerous encapsulationschemes may be relevant to the inclusion of a Component device layer210. In some embodiments, the layers 210 may be adhered to otherComponents, such as, for example, an active optical device 220, beforethe resulting insert is then fixed into an ophthalmic device as depictedin FIG. 1. The active optical device 220 may be a liquid meniscus-typeLens filled with two different immiscible fluids and then sealed.

Seals and Encapsulating Features—Glue Groove

Proceeding to FIG. 3, a magnified cross section of the edge 300 of anexemplary optical device 220 is shown. For example, the aqueous phase360 and the nonaqueous phase 350 may represent the two immiscible fluidsin a meniscus-type Lens. The front surface 310 of the active device maybe a molded separate piece onto which various electrode metal layers mayhave been deposited. The molded front piece 310 may have a glue groove,recess, or slot 320, which will then intersect with the molded, butseparate, back piece 340. This glue groove 320 may serve as a receptaclefor an adhesive, sealant, or glue, as examples. After the Front CurvePiece 310 and the Back Curve Piece 340 are brought into proximity toeach other, either before or after the fluids 350 and 360 fill a cavityformed by the two pieces 310 and 340, the Back Curve Piece 340 may beadvanced to firmly register into the glue groove 320. Thereafter, anadhesive 330 may be deposited into the remaining space of the gluegroove 320 to create a sealed region 330. In some embodiments, this gluegroove 320 may be located around the entire periphery of the Lens deviceitself.

Numerous methods may effectively apply adhesives into the glue groove320. Some embodiments may include application by spray nozzles, as with,for example, printing equipment, or other embodiments may deposit intothe glue groove 320 preformed adhesives, which are then either caused toflow and bond by heat light, pressure, or other standard means offorming seals and bonds. Many types of adhesives may form the sealedregion 330. Table 1 lists some examples of the types of materials thatmay be utilized for this sealing application and possible respectiveembodiments. Table 1 also describes some representative characteristicsof some materials in each of the categories. One ordinarily skilled inthe art will recognize that materials other than those discussed mayalso be included within the scope of the claims.

TABLE 1 Partial Listing of exemplary sealing materials, encapsulatingmaterials and coating materials Material Exemplary aspects of utilityEpoxy Systems One Component - high temp cure, excellent adhesive,biocompatible Two Component - fast cure at ambient, biocompatibility,gap filling Silicone Systems One Component - resistance to humidity,high flexibility, Insulation, Optical Clarity Two Component - Strength,Superior Flexibility, biocompatibility UV Curable Fast Cure, grades withFlexibility, vapor free Systems LED Curable One Component, LowTemperature applications Systems Polyurethanes Optical Clarity,Insulation, Flexibility Polysulfides Underwater cure, high Strength,high chem resistance Cyanoacrylates Biocompatibility, single compound,no outgassing Elastomeric Excellent water resistance, Insulation, singleSystems compound Film Adhesives Preform-ability, excellent insulationcharacteristics Hot Melt Systems Food Contact Grades Latex SystemsPressure Sensitive Applications, Food Contact Grades PolyimidesPhotosensitive, Preform-ability, Flexibility Parylenes (Vapor SurfaceTreatment, Insulation, Conformal Application Phase Film Dep)

FIGS. 4A and 4B illustrate a different embodiment 400 with a glue groove495. This embodiment may be comprised of a two-piece assembly with aFront Curve Piece 410 and Back Curve Piece 492 with a cavity between thetwo pieces 410 and 492 used to house an active optical device, such as,for example, a meniscus-type Lens. The Front Curve Piece 410 may bemolded or formed to be larger than the size of the active opticalelement wherein the extra dimension creates a support area 415, whichprovides a mounting surface for Components, interconnects, andeventually numerous types of sealing aspects. FIG. 4A illustrates anenlarged Front Curve Piece 410 from top down.

Various electrical interconnects and interconnect features 430 and 440may be located on this enlarged Front Curve Piece 410. In someembodiments, these interconnect features 430 and 440 may connect toenergization elements, such as, for example, batteries. In otherembodiments, the energization elements may be deposited or attached uponthe electrical interconnects along the interconnect lines 430, 440, 470and 480. In some specific embodiments, a first interconnect may beattached to a second interconnect 480 via a crossover 420. Connectionpoints 450 and 460 may be used to interconnect the energization elementsto other elements.

Elements may be formed from materials that may or may not be stable inthe environments that ophthalmic devices occupy, including, for example,the tear fluid on an ocular surface that contacts the element. The usemay include forming encapsulation layers from coatings, including, forexample, a parylene family including, but not limited to, the paryleneC, N, and D family elements. In some embodiments, the encapsulationcoating may occur before or after application of other adhesive orsealant layers.

FIG. 4B represents a direction of cross section to form the lower crosssection image in the figure. As mentioned above, some embodimentsinclude interconnect features, such as, for example, a connection point,where Components 491 are attached. An exemplary Component 491 mayinclude, for example, an integrated circuit attached to the connectionpoint 460 by conductive epoxy as an example of a conductive material. Insome embodiments, the attached Components 491 may typically be adheredto a support area 415 of the Front Curve Piece 410 via the under-fillingof adhesive underneath, or in between, the Component body and theattaching surface. Coatings or adhesives may also subsequently beapplied to the integrated circuit or other Component 491 to encapsulateit and connect it to the Front Curve Piece 410. As shown in the crosssection image, there may be a back curve feature 493. The nature of theseal designs that derive from an embodiment 490 with this back curvefeature 493 will be discussed in the following sections in some detail.

In another aspect, in some embodiments, a colorant layer 496 may beincluded along a periphery region to modify the visualize appearance ofthe lens. The colorant layer may be added for example, via a padprinting or ink jet type process.

Proceeding to FIG. 5, this embodiment 500 includes exemplary sealingfeatures of the two-piece insert embodiments in FIGS. 4A and 4B. A FrontCurve Piece 540 of a Multi-Piece Insert, in some embodiments, as in theone shown, may contain a molded or formed feature 525 that may serve thedual purpose of defining one side of a glue seal region 520 andproviding a surface upon which electrodes may be deposited for variouspurposes. In some embodiments, like that shown, the Front Curve Piece540 may include a protrusion 515 to serve as an opposite side of a glueseal region 520. The Back Curve Piece 510 of the Multi-Piece Insert mayhave a molded feature that forms the mating surface for the glue sealregion 515. In this embodiment, the Back Curve Piece 510 has atwo-feature mating surface, which then defines an interior cavity region530 and an exterior region 520 of the resulting glue seal.

In some embodiments, the glue seal regions 525 and 515 may be filledwith an adhesive before the Back Curve Piece 510 is located into place,causing the adhesive to flow around the two sealing regions 520 and 530.Alternatively, the glue seal region 530 may be filled before the BackCurve Piece 510 is moved into place against the Front Curve Piece 540,allowing the adhesive to flow around the cavity forming both a seal anda bond. In some embodiments, the glue seal region 520 may be filled withan adhesive in a separate step that may include the same or differentmaterial from the first cavity-filling step. The various materials ofTable 1 may be used in said embodiments 500. This includes, but is notlimited to, the use of adhesives to function under aqueous conditions orthe use of relatively solid preformed sealants to fill the glue sealregion 530.

In other embodiments, the sealing system 515, 520, 530, 525, 510 may belocated closer to the outer edge 560 of the Front Curve Piece 540. Theminimum distance between the glue seal region 515 and the outer edge 560still allows for the housing and support of a Component 491, such as,for example, integrated circuitry.

Other alternative embodiments may include a flap, extension, orappendage 550 that extends the Back Curve Piece 510 to as far as theouter edge 560 of the Front Curve Piece 540. This appendage 550 mayserve a dual purpose of strengthening the glue seal region 520 andfurther protecting the Component 491.

In FIG. 6, another exemplary embodiment 600 includes a Front Curve Piece640 of a Multi-Piece Insert and a Back Curve Piece 650. In thisembodiment, the glue seal region may span the interior cavity 620between the Back Curve Piece 650 and the Front Curve Piece 640 from aformed feature 625 to the outer edge 615 and may be modified to includethe Component 491, such as, for example, interconnection and integratedcircuitry. The formed feature 625 may have a dual purpose of defining aglue seal region 620 from 625 to 615 and providing mounting surface forformed electrodes.

In another alternative embodiment, the design of the Back Curve Piece650 feature 610 that resides in the glue seal region 620 from 625 to 615may be a single feature 610. In this exemplary embodiment, the interiorcavity 620 is formed by a flap feature 660 and a sealing feature 610into the glue seal region 620 from 625 to 615. The materials of Table 1provide examples of the materials that may be effective in sealing andencapsulation of the insert device. From a general perspective, it maybe obvious to one skilled in the art that numerous embodiments of theglue seal regions and the Front Curve Piece and Back Curve Piecefeatures may be practical, and such devices are well within the scope ofthe claims.

Seals and Encapsulating Features—Compression Seal

FIG. 7 illustrates an alternate embodiment that includes a differenttype of seal system 745 and 720 that may seal a Multi-Piece Insertdevice 700. In some embodiments, the nature of at least one of the sealsmay involve a compression seal between two surfaces. This embodiment 700includes an exemplary Back Curve Piece 740 with a surface 745 thatcompresses another sealing feature 720, which may be formed as adeposited seal from various adhesive materials, including, for example,the materials listed in Table 1.

In a specific embodiment, the sealing feature 720 may be an elastomerico-ring that is placed into a groove 750 in the Front Curve Piece 310,which creates a compressed location for the sealing features 720 and745. When pressure is applied to the Front Curve Piece 310 and the BackCurve Piece 740, a compression seal may form between a sealing feature745 on the Back Curve Piece 740 and the sealing feature 720 in thegroove 750. In some embodiments, an adhesive may be placed into the restof the sealing groove 730 to lock the Front Curve Piece 310 and the BackCurve Piece 740 into the groove 750. In this embodiment, acompression-type seal in an ophthalmic device contains a fluid-basedliquid meniscus embodiment; in other embodiments, this type of seal maybe used for sealing needs in the ophthalmic Lens environment, such as,for example, the sealing system demonstrated in FIG. 6.

Seals and Encapsulating Features—Knife-Edge Seal

FIG. 8 includes an alternative embodiment of a seal that may be formedto seal a Multi-Piece Insert device 800. In said embodiments, the natureof at least one of the seals may involve a knife-edge seal 845 between aBack Curve Piece 840 and a Front Curve Piece 310. An exemplary BackCurve Piece 840 may have a sharpened surface 845 that can lock intoanother sealing feature 820. In some embodiment, the sealing feature 820may be formed as a deposited seal using, for example, the adhesivematerials in Table 1. Other embodiments may include an o-ring typepreformed feature 820 that may be placed into a groove 850 wherein theknife-edge feature 845 may be compressed into the sealing feature 820.Alternatively, an uncured or cured adhesive material may be applied tothe groove 850 to create a sealing feature 820 into which the knife-edgefeature 845 may be forced. In embodiments where the sealing feature 820is uncured adhesive, the Front Curve Piece 310 and the Back Curve Piece840 may be sealed and adhesively affixed by the surface formed by theknife-edge surface 845 into the sealing feature 820.

In other embodiments, regardless of the nature of the seal formed withthe sealing feature 820, a subsequent exemplary step may include placingan adhesive into the rest of the sealing groove 830 to lock the FrontCurve Piece 310 and the Back Curve Piece 840 into place. In thisspecific embodiment, the knife-edge sealing system 845, 820, and 850 inthe ophthalmic device 800 is based on a fluid-based liquid meniscusembodiment. This type of sealing system 845, 820, and 850 could also beeffective in other types of sealing need in the ophthalmic Lensenvironment, such as, for example, the sealing of the type demonstratedin FIG. 6.

FIG. 9 illustrates an alternative embodiment of a knife-edge type sealin an ophthalmic insert device 900. In this embodiment based around afluid-based liquid meniscus embodiment, a Front Curve Piece 310 of aMulti-Piece Insert and a Back Curve Piece 940 are locked together usinga self-locking mechanism to seal and encapsulate said Multi-Piece Insertdevice 900. A self-locking mechanism 960 utilizes a profile lip 970extending from the knife-edge feature 945 on the Back Curve Piece 940and a slot groove 960 on the Front Curve Piece 310. When the Front CurvePiece 310 and the Back Curve Piece 960 are pushed together, the profilelip 970 and the slot groove 960 create a positively locked junction. Inthe example embodiment, the groove 950 may also create a compressionlocation to further secure the knife-edge feature 945 into the sealingfeature 920. It may be clear that any of the related sealing embodimentsother than a knife-edge may constitute art within the inventive scopeherein.

Another optional feature of this embodiment may include a recess 930along the entire periphery of the self-locking sealing mechanism 920,945, 970, 960, and 950. Said recess 930 can accept an adhesive orsealant, such as, for example, the material listed in Table 1. Thisembodiment 900 depicts a single sealing location, but other embodimentsmay require multiple sealing locations. For example, in the device 400in FIG. 4A, a self-locking sealing mechanism 920, 945, 970, 960, and 950may provide additional diversity of uses for the concepts embodied bythe claims. A first sealing surface may be useful for sealing the fluidcontaining regions of the center of the Lens, while a second annularringed piece may be subsequently placed with an inner annular seal andan outer annular seal to enclose the interconnect, energization andelectronic Components. The Back Curve Piece may be formed in such amanner to extend as one piece over all the regions. With multiplesealing surfaces for the different regions, the various sealingembodiments may be combined or used in multiple locations.

Methods and Materials for Insert-Based Ophthalmic Lenses

Referring back to FIG. 1, a diagram of an exemplary Mold device 100 foran ophthalmic Lens is illustrated with a Multi-Piece Insert 104. As usedherein, a Mold device 100 includes a plastic formed to shape a cavity106 into which a Lens-Forming Mixture can be dispensed such that uponreaction or cure of the Lens-Forming Mixture, an ophthalmic Lens of adesired shape is produced. The Molds and Mold assemblies 100 of thisinvention are comprised of more than one Mold parts or Mold pieces 101and 102. The Mold parts 101 and 102 can be brought together in a mannerthat forms a cavity 106 between the Mold parts 101 and 102 in which aLens can be formed. This combination of Mold parts 101 and 102 ispreferably temporary. Upon formation of the Lens, the Mold parts 101 and102 can again be separated for removal of the Lens.

At least one Mold part 101 and 102 has at least a portion of its surfacein contact with the Lens-Forming Mixture so that upon reaction or cureof the Lens-Forming Mixture the surface provides a desired shape andform to the portion of the Lens with which it is in contact. The same istrue of at least one other Mold part 101 and 102.

Thus, for example, in an exemplary embodiment a Mold device 100 isformed from two parts 101 and 102, a female concave piece (front curveMold) 102 and a male convex piece (back curve Mold) 101 with a cavity106 formed between them. The portion of the concave surface that makescontact with a Lens-Forming Mixture has the curvature of the front curveof an ophthalmic Lens to be produced in the Mold device 100. Saidportion is sufficiently smooth and formed such that the surface of anophthalmic Lens, formed by polymerization of the Lens-Forming Mixturethat is in contact with the concave surface, is optically acceptable.

In some embodiments, the front curve Mold 102 can also have an annularflange integral to and surrounding a circular circumferential edge thatextends from the front curve Mold 120 in a plane normal to the axis andalso extends from the flange (not shown).

A Lens-Forming Surface can include a surface with an optical-qualitysurface finish, which indicates that it is sufficiently smooth andformed so that a Lens surface fashioned by the polymerization of aLens-Forming Mixture in contact with the molding surface is opticallyacceptable. Further, in some embodiments, the Lens-Forming Surfaces ofMold pieces 101 and 102 can have a geometry that is necessary to impartto the Lens surface the desired optical characteristics, including, butnot limited to, spherical, aspherical, and cylinder power; wave frontaberration correction; corneal topography correction; and combinationsthereof. One ordinarily skilled in the art will recognize thatcharacteristics other than those discussed may also be included withinthe scope of the invention.

An Energy Source and a Component are mounted on a Multi-Piece Insert104, which may be comprised of any receiving material onto which anEnergy Source may be placed. In some embodiments, the Multi-Piece Insert104 may also include, for example, circuit paths, Components, and otheraspects useful to placing the Energy Source in electrical communicationwith the Component and enabling the Component to draw an electricalcurrent from the Energy Source. The novel sealing and encapsulatinginnovations discussed herein, such as, for example, a sealed surface105, allow for a functional insert to be manufactured in multiple piecesand then reliably assembled and sealed for eventual inclusion into anophthalmic device, wherein materials in the ambient of the ophthalmicdevice and materials inside the insert device cannot diffuse through theinsert materials or said seals 105.

Various embodiments also include placing an Energy Source into aMulti-Piece Insert 104 prior to placing the Multi-Piece Insert 104 intoa Mold portion used to form a Lens. The Multi-Piece Insert 104 may alsoinclude one or more Components that will receive an electrical chargevia the Energy Source.

In some embodiments, a Lens with a Multi-Piece Insert 104 can include arigid center, soft skirt design wherein a central rigid optical elementis in direct contact with the atmosphere and the corneal surface onrespective anterior and posterior surfaces. The soft skirt of Lensmaterial (typically a hydrogel material) is attached to a periphery ofthe rigid optical element, which also acts as a Multi-Piece Insertproviding energy and functionality to the resulting ophthalmic Lens. Inthese embodiments, the function of encapsulants and seals 105 areimportant.

Some additional embodiments include a Multi-Piece Insert 104 that is arigid Lens insert and fully encapsulated within a hydrogel matrix. AMulti-Piece Insert 104 that is a rigid Lens insert may be manufactured,for example, using microinjection-molding technology. Embodiments caninclude, for example, a poly(4-methylpent-1-ene) copolymer resin with adiameter of between about 6 mm to 10 mm and a front surface radius ofbetween about 6 mm and 10 mm and a rear surface radius of between about6 mm and 10 mm and a center thickness of between about 0.050 mm and 0.5mm. Some exemplary embodiments include an insert with diameter of about8.9 mm, a front surface radius of about 7.9 mm, a rear surface radius ofabout 7.8 mm, a center thickness of about 0.100 mm, and an edge profileof about 0.050 radius. One exemplary micromolding machine can includethe Microsystem 50 five-ton system offered by Battenfield Inc. Some orall of the sealing features, including, but not limited to, grooves,slots, lips, and knife edges may be formed during the molding process orformed later by subsequent processing of the result of the moldingprocess.

The Multi-Piece Insert can be placed in a Mold part 101 and 102 utilizedto form an ophthalmic Lens. Mold part 101 and 102 material can include,for example, a polyolefin of one or more of the following:polypropylene, polystyrene, polyethylene, polymethyl methacrylate, andmodified polyolefins. Other Molds can include a ceramic or metallicmaterial.

Other Mold materials that may be combined with one or more additives toform an ophthalmic Lens Mold include, for example, Zieglar-Nattapolypropylene resins (sometimes referred to as znPP); a clarified randomcopolymer for clean molding as per FDA regulation 21 CFR (c) 3.2; arandom copolymer (znPP) with ethylene group.

Still further, in some embodiments, the Molds of the invention maycontain polymers such as polypropylene, polyethylene, polystyrene,polymethyl methacrylate, modified polyolefins containing an alicyclicmoiety in the main chain and cyclic polyolefins. This blend can be usedon either or both Mold halves. Preferably, this blend is used on theBack Curve Piece, and the Front Curve Piece consists of the alicyclicco-polymers.

In some preferred methods of making Molds 100 according to the presentinvention, injection molding is utilized according to known techniques.Embodiments can also include Molds fashioned by other techniquesincluding, for example, lathing, diamond turning, or laser cutting.

Typically, Lenses are formed on at least one surface of both Mold parts101 and 102. However, in some embodiments, one surface of a Lens may beformed from a Mold part 101 and 102, and another surface of a Lens canbe formed, for example, using a lathing method.

In some embodiments, a Multi-Piece Insert 400 may have a front curvesurface 410 with an Optical Zone that includes a variable optic poweredby an Energy Source 420, 430, 440, 470, and 480 located on theMulti-Piece Insert 400. The Multi-Piece Insert 400 can also include aComponent 491, such as, for example, integrated circuitry, to controlthe variable optic included in the Optical Zone. In this discussion, avariable optic can be considered a Component.

An Energy Source can be in electrical communication with a Component491. The Component 491 can include any device that responds to anelectrical charge with a change in state, such as, for example, asemiconductor-type chip, a passive electrical device, or an opticaldevice such as a crystal Lens.

In some specific embodiments, an Energy Source 420, 430, 440, 470, and480 includes, for example, battery or other electrochemical cell,capacitor, ultracapacitor, supercapacitor, or other storage Component.Some specific embodiments can include a battery located on a Multi-PieceInsert 400 on the periphery of an ophthalmic Lens outside of the OpticalZone.

In some embodiments, a Lens type can include a Lens that includes asilicone-containing Component. A silicone-containing Component is onethat contains at least one [—Si—O—] unit in a monomer, macromer, orprepolymer. Preferably, the total silicone and attached oxygen arepresent in the silicone-containing Component in an amount greater thanabout 20 weight percent, and more preferably greater than 30 weightpercent of the total molecular weight of the silicone-containingComponent. Useful silicone-containing Components preferably comprisepolymerizable functional groups such as acrylate, methacrylate,acrylamide, methacrylamide, vinyl, N-vinyl lactam, N-vinylamide, andstyryl functional groups.

In some embodiments, the ophthalmic Lens skirt, also called aninsert-encapsulating layer, that surrounds the insert may be comprisedof standard hydrogel Lens formulations. Exemplary materials withcharacteristics that may provide an acceptable match to numerous insertmaterials may include, but are not limited to, the Narafilcon family(including Narafilcon A and Narafilcon B), and the Etafilcon family(including Etafilcon A). A more technically inclusive discussion followson the nature of materials consistent with the art herein. Oneordinarily skilled in the art may recognize that other material otherthan those discussed may also form an acceptable enclosure or partialenclosure of the sealed and encapsulated inserts and should beconsidered consistent and included within the scope of the claims.

Suitable silicone-containing Components include compounds of Formula I

wherein R¹ is independently selected from monovalent reactive groups,monovalent alkyl groups, or monovalent aryl groups, any of which mayfurther comprise functionality selected from hydroxy, amino, oxa,carboxy, alkyl carboxy, alkoxy, amido, carbamate, carbonate, halogen orcombinations thereof; monovalent siloxane chains comprising 1-100 Si—Orepeat units that may further comprise functionality selected fromalkyl, hydroxy, amino, oxa, carboxy, alkyl carboxy, alkoxy, amido,carbamate, halogen, or combinations thereof;

where b is 0 to 500, where it is understood that when b is other than 0,b is a distribution having a mode equal to a stated value;

wherein at least one R¹ comprises a monovalent reactive group and, insome embodiments, between one and three R¹ comprise monovalent reactivegroups.

As used herein, monovalent reactive groups are groups that can undergofree radical and/or cationic polymerization. Non-limiting examples offree radical reactive groups include (meth)acrylates, styryls, vinyls,vinyl ethers, C₁₋₆alkyl(meth)acrylates, (meth)acrylamides,C₁₋₆alkyl(meth)acrylamides, N-vinyllactams, N-vinylamides,C₂₋₁₂alkenyls, C₂₋₁₂alkenylphenyls, C₂₋₁₂alkenylnaphthyls,C₂₋₆alkenylphenylC₁₋₆alkyls, O-vinylcarbamates, and O-vinylcarbonates.Non-limiting examples of cationic reactive groups include vinyl ethersor epoxide groups and mixtures thereof. In one embodiment the freeradical reactive groups comprise (meth)acrylate, acryloxy,(meth)acrylamide, and mixtures thereof.

Suitable monovalent alkyl and aryl groups include unsubstitutedmonovalent C₁₋₁₆alkyl groups, C₆₋₁₄ aryl groups, such as substituted andunsubstituted methyl, ethyl, propyl, butyl, 2-hydroxypropyl,propoxypropyl, polyethyleneoxypropyl, combinations thereof, and thelike.

In one embodiment, b is 0, one R¹ is a monovalent reactive group, and atleast three R¹ are selected from monovalent alkyl groups having 1 to 16carbon atoms or, in another embodiment, from monovalent alkyl groupshaving 1 to 6 carbon atoms. Non-limiting examples of silicone Componentsof this embodiment include2-methyl-,2-hydroxy-3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]disiloxanyl]propoxy]propylester (“SiGMA”),2-hydroxy-3-methacryloxypropyloxypropyl-tris(trimethylsiloxy)silane,3-methacryloxypropyltris(trimethylsiloxy)silane (“TRIS”),3-methacryloxypropylbis(trimethylsiloxy)methylsilane, and3-methacryloxypropylpentamethyl disiloxane.

In another embodiment, b is 2 to 20, 3 to 15 or, in some embodiments, 3to 10; at least one terminal R¹ comprises a monovalent reactive groupand the remaining R¹ are selected from monovalent alkyl groups having 1to 16 carbon atoms or, in another embodiment, from monovalent alkylgroups having 1 to 6 carbon atoms. In yet another embodiment, b is 3 to15, one terminal R¹ comprises a monovalent reactive group, the otherterminal R¹ comprises a monovalent alkyl group having 1 to 6 carbonatoms, and the remaining R¹ comprise monovalent alkyl group having 1 to3 carbon atoms. Non-limiting examples of silicone Components of thisembodiment include (mono-(2-hydroxy-3-methacryloxypropyl)-propyl etherterminated polydimethylsiloxane (400-1000 MW)) (“OH-mPDMS”), andmonomethacryloxypropyl terminated mono-n-butyl terminatedpolydimethylsiloxanes (800-1000 MW) (mPDMS).

In another embodiment, b is 5 to 400 or from 10 to 300, both terminal R¹comprise monovalent reactive groups, and the remaining R¹ areindependently selected from monovalent alkyl groups having 1 to 18carbon atoms, which may have ether linkages between carbon atoms and mayfurther comprise halogen.

In one embodiment, where a silicone hydrogel Lens is desired, the Lensof the present invention will be made from a Reactive Mixture comprisingat least approximately 20 and preferably between approximately 20 and 70percent weight silicone-containing Components based on total weight ofreactive monomer Components from which the polymer is made.

In another embodiment, one to four R¹ comprises a vinyl carbonate orcarbamate of Formula II

wherein Y denotes O—, S— or NH—; and R denotes hydrogen or methyl; d is1, 2, 3, or 4; and q is 0 or 1.

The silicone-containing vinyl carbonate or vinyl carbamate monomersspecifically include1,3-bis[4-(vinyloxycarbonyloxy)but-1-yl]tetramethyl-disiloxane;3-(vinyloxycarbonylthio)propyl-[tris(trimethylsiloxy)silane];3-[tris(trimethylsiloxy)silyl]propyl allyl carbamate;3-[tris(trimethylsiloxy)silyl]propyl vinyl carbamate;trimethylsilylethyl vinyl carbonate; trimethylsilylmethyl vinylcarbonate, and

Where biomedical devices with modulus below approximately 200 aredesired, only one R¹ shall comprise a monovalent reactive group and nomore than two of the remaining R¹ groups will comprise monovalentsiloxane groups.

Another class of silicone-containing Components includes polyurethanemacromers of the following formulae:(*D*A*D*G)_(a)*D*D*E¹;E(*D*G*D*A)_(a)*D*G*D*E¹ or;E(*D*A*D*G)_(a)*D*A*D*E¹  Formulae IV-VI

wherein D denotes an alkyl diradical, an alkyl cycloalkyl diradical, acycloalkyl diradical, an aryl diradical, or an alkylaryl diradicalhaving 6 to 30 carbon atoms;

wherein G denotes an alkyl diradical, a cycloalkyl diradical, an alkylcycloalkyl diradical, an aryl diradical or an alkylaryl diradical having1 to 40 carbon atoms and which may contain ether, thio or amine linkagesin the main chain;

* denotes a urethane or ureido linkage;

_(a) is at least 1; and

A denotes a divalent polymeric radical of formula:

wherein R¹¹ independently denotes an alkyl or fluoro-substituted alkylgroup having 1

to 10 carbon atoms, which may contain ether linkages between carbonatoms; y is at least 1; and p provides a moiety weight of 400 to 10,000;each of E and E¹ independently denotes a polymerizable unsaturatedorganic radical represented by Formula VIIIwherein R¹² is hydrogen or methyl; R¹³ is hydrogen, an alkyl radicalhaving 1 to 6 carbon atoms, or a —CO—Y—R¹⁵ radical wherein Y is —O—,Y—S— or —NH—; R¹⁴ is a divalent radical having 1 to 12 carbon atoms; Xdenotes —CO— or —OCO—; Z denotes —O— or —NH—; Ar denotes an aromaticradical having 6 to 30 carbon atoms; w is 0 to 6; x is 0 or 1; y is 0 or1; and z is 0 or 1.

A preferred silicone-containing Component is a polyurethane macromerrepresented by Formula IX (the full structure may be understood byjoining corresponding asterisk regions, * to *, ** to **)

wherein R¹⁶ is a diradical of a diisocyanate after removal of theisocyanate group, such as the diradical of isophorone diisocyanate.Another suitable silicone-containing macromer is a compound of formula X(in which x+y is a number in the range of 10 to 30) formed by thereaction of fluoroether, hydroxy-terminated polydimethylsiloxane,isophorone diisocyanate and isocyanatoethylmethacrylate. Formula X (thefull structure may be understood by joining corresponding asteriskregions, * to *)

Other silicone-containing Components suitable for use in this inventioninclude macromers containing polysiloxane, polyalkylene ether,diisocyanate, polyfluorinated hydrocarbon, polyfluorinated ether, andpolysaccharide groups; polysiloxanes with a polar fluorinated graft orside group having a hydrogen atom attached to a terminaldifluoro-substituted carbon atom; hydrophilic siloxanyl methacrylatescontaining ether and siloxanyl linkanges and crosslinkable monomerscontaining polyether and polysiloxanyl groups. Any of the foregoingpolysiloxanes can also be used as the silicone-containing Component inthis invention.

Processes

The following method steps are provided as examples of processes thatmay be implemented according to some aspects of the present invention.It should be understood that the order in which the method steps arepresented is not meant to be limiting and other orders may be used toimplement the invention. In addition, not all of the steps are requiredto implement the present invention and additional steps may be includedin various embodiments of the present invention. It may be obvious toone skilled in the art that additional embodiments may be practical, andsuch methods are well within the scope of the claims.

Referring now to FIG. 10, a flowchart illustrates exemplary steps thatmay be used to implement the present invention. At 1001, a Front CurvePiece, such as, for example, that piece 310 shown in FIG. 3, is formed,and at 1002 a Back Curve Piece, such as, for example, the piece 340shown in FIG. 3, is formed. These formation steps at 1001 and 1002 maybe performed in either order or simultaneously.

At 1003, a conductive material may be applied to either or both theFront Curve Piece of the insert or the Back Curve Piece of the insert.At 1004, a sealing agent may be applied to at least a portion of eitheror both the electrical Component and the conductive material. Thisapplication at 1004 of sealing agent to the conductive material mayoccur throughout the sealing process, whereas the application at 1004 tothe electrical Component may occur once the Component has been attachedto the conductive material at 1003.

At 1005, an adhesive or sealing material may be applied to either orboth of the Front Curve Piece and the Back Curve Piece. In someembodiments, the application of this material may involve the placementof a preformed piece upon one or both of the insert pieces. In someadditional embodiments, there may be more than one Front Curve Piece orone Back Curve Piece or more than one of both pieces. In theseembodiments, the step at 1005 would be repeated until all applicablepieces of the ophthalmic insert are combined into an insert.

The combination at 1005 of Front Curve Pieces to Back Curve Piecesinherently creates a cavity that may house, for example, as shown inFIG. 2, an active optical device 220. At 1006, said cavity may be atleast partially filled with fluid. In some embodiments, the fluids mayserve multiple functions, and multiple fluids may be added by repeatingthe step at 1006. For example, as illustrated in FIG. 3, two immisciblefluids 350 and 360 may create a meniscus-type Lens.

At 1007, a reactive monomer mix can be deposited between a first Moldpart and a second Mold part or onto a surface of either the first or thesecond Mold part that will be between the two parts as a result ofsubsequent processing steps. At 1008, the combined insert is placed intoa cavity formed by the first Mold part and the second Mold part or ontoa surface that will be in a cavity formed by the first Mold part and thesecond Mold part at a later time. In some preferred embodiments, thecombined insert 104 of FIG. 1 is placed in the Mold part 101 and 102 ofFIG. 1 via mechanical placement. Mechanical placement can include, forexample, a robot or other automation, such as, for example, those knownin the industry to place surface mount Components. Human placement of aninsert 104 is also within the scope of the present invention.Accordingly, any mechanical placement is effective so long as it placesan insert 104 within a cast Mold part such that the polymerization of aReactive Mixture contained by the Mold part will include the insert in aresultant ophthalmic Lens. In some embodiments, a processor device,MEMS, NEMS, or other Component may also be mounted in or on the insertand be in electrical communication with an Energy Source.

At 1009, the first Mold part can be placed proximate to the second Moldpart to form a Lens-forming cavity with at least some of the reactivemonomer mix and the Energy Source in the cavity. At 1010, the ReactiveMonomer Mix within the cavity can be polymerized. Polymerization can beaccomplished, for example, via exposure to one or both of actinicradiation and heat. At 1011, the Lens is removed from the Mold parts.

Although the invention may be used to provide hard or soft contactLenses made of any known Lens material, or material suitable formanufacturing such Lenses, preferably, the Lenses of the invention aresoft contact Lenses having water contents of approximately 0 to 90percent. More preferably, the Lenses are made of monomers containingeither or both hydroxy groups and carboxyl groups, or be made fromsilicone-containing polymers, such as siloxanes, hydrogels, siliconehydrogels, and combinations thereof. Material useful for forming theLenses of the invention may be made by reacting blends of macromers,monomers, and combinations thereof along with additives such aspolymerization initiators. Suitable materials include, withoutlimitation, silicone hydrogels made from silicone macromers andhydrophilic monomers.

Apparatus

Referring now to FIG. 11, an embodiment 1100 of an automated apparatus1110 is illustrated with one or more insert 1114 transfer interfaces1111. As illustrated, multiple Mold parts, each with an associatedinsert 1114, are contained on a pallet 1112 and presented to a mediatransfer interface 1111. Embodiments can include a single interfaceindividually placing Multi-Piece Inserts 1114 or multiple interfaces(not shown) simultaneously placing Multi-Piece Inserts 1114 in multipleMold parts, and in some embodiments, in each Mold.

Another aspect of some embodiments includes apparatus to support theMulti-Piece Insert 1114 while the body of the ophthalmic Lens is moldedaround these Components. The holding points may be affixed withpolymerized material of the same type that will be formed into the Lensbody.

Referring now to FIG. 12, a controller 1200 is illustrated that may beused in some embodiments of the present invention. The controller 1200includes one or more processors 1210, which may include one or moreprocessor Components coupled with a communication device 1220. In someembodiments, a controller 1200 can be used to transmit energy to anEnergy Source placed in the ophthalmic Lens. In some embodiments, allthe aforementioned Components may be located within a Multi-Piece Insertwhere the multiple pieces are sealed to define interior and exteriorregions of the insert.

The processors 1210 are coupled with a communication device 1220configured to communicate energy via a communication channel. Thecommunication device 1220 may be used to electronically control one ormore of the automation used in the placement of an insert into theophthalmic Lens Mold part, the transfer of digital data to and from aComponent mounted on or in an the insert media and placed within anophthalmic Lens Mold part, or the Component incorporated into theophthalmic Lens. The communication device 1220 may also be used tocommunicate, for example, with one or more controller apparatus ormanufacturing equipment Components.

The processor 1210 is also in communication with a storage device 1230.The storage device 1230 may comprise any appropriate information storagedevice, including, but not limited to, combinations of magnetic storagedevices such as magnetic tape and hard disk drives, optical storagedevices, and/or semiconductor memory devices such as Random AccessMemory (RAM) devices and Read Only Memory (ROM) devices.

The storage device 1230 can store a program 1240 for controlling theprocessor 1210. The processor 1210 performs instructions of a softwareprogram 1240 and thereby operates in accordance with the presentinvention. For example, the processor 1210 may receive informationdescriptive of an insert placement or Component placement. The storagedevice 1230 can also store ophthalmic-related data in one or moredatabases 1250 and 1260. The database may include customized insertdesigns, metrology data, and specific control sequences for controllingenergy to and from an insert.

Seal and Encapsulating Features—Annular Pieces

In some embodiments, the various aspects that have been discussed may beuseful in different shaped devices. Proceeding to FIG. 13A, anannular-type insert device 1300 is illustrated. In contrast to previousembodiments wherein a central optic region may include active ophthalmicdevices, in embodiments with all annular pieces, the central opticregion 1310 may be devoid of material.

In annular types of embodiments, the resulting insert device 1300 maystill be placed into an ophthalmic Lens. Similar to previousdiscussions, the annular device 1300 may be centered into a moldingapparatus that may insert various materials, including, for example,hydrogel materials, to define the characteristics of the ophthalmicdevice.

An annular insert device 1300 may have different features and uses dueto its shape. For example, a sealing edge 1315 may be present, whichwould not be present in embodiments where the Optical Zone is includedin either or both of the Front Curve Piece and Back Curve Pieces, asshown, for example, in FIG. 3 with pieces 310 and 340, respectively. Asshown as an example in the cross-sectional view, FIG. 13B, a sealingfeature 1393 may utilize or reinforce the sealing edge 1315.Additionally, the presence of this new sealing edge 1315 may allow forother functions such as, for the example, the ability to make portionsof the sealing edge 1315 porous to fluids in the environment. In otherembodiments, such porous characteristics may also be introduced into thesurface portions of the insert device 1300. The use of a sealing feature1393 where electrical traces traverse the seal edge 1315 may createsealable cavities and may allow interaction with devices likeenergization elements and electrical Components that may reside in saidsealable cavities.

Nevertheless, the inner periphery seal-edge feature 1393 of an annularinsert device 1300 creates a unique environment for such function sinceit may have electrical conductive traces 1380 that pass through the sealedge 1315 and onto other devices. Returning to FIG. 13A, the annularinsert device 1300 may have a void in the central optic region 1310. Thecentral optic region 1310 may include a seal edge 1315 that may besealed by the various embodiments disclosed herein. Electricallyconductive traces 1330 and 1340 may be deposited on the annular insertdevice 1300. In some embodiments, these traces 1330 and 1340 may haveenergization elements deposited or attached to them, such as, forexample, an integrated circuit 1360 that has been connected to theelectrically conductive traces 1330 and 1340. There may be furtherconnections to additional electrically conductive traces 1370 and 1380.These traces 1330, 1340, 1370, and 1380 may connect to a sensing feature1395 that may be able to monitor the wearer, including, but not limitedto gauging changes in conductivity of the tear fluid in the spacesurrounding the sensing feature 1395. One ordinarily skilled in the artwill recognize that numerous types of sensing devices may be practical,and such embodiments are well within the scope of the claims.

In other embodiments, the traces 1370 and 1380 may be useful to controlthe dispensing of fluids or medicament from the sensing feature 1395.The location and presence of the sensing feature 1395 relative to theembodiment 1300 are demonstrated for exemplary purposes only, and suchfunction may be included at any portion of the surface features of theannular insert device 1300. One ordinarily skilled in the art willrecognize that aspects of the sealing methodology discussed herein maybe utilized in such locations.

Continuing with the cross sectional representation FIG. 13B, a firstsealing feature 1391 may allow for the sealing of the Front Curve Piece1320 to the Back Curve Piece 1325. An annular feature inherently has aninner and outer periphery, allowing for a seal 1393 to be formed alongthe said inner periphery. Embodiments of annular insert devices mayadditionally include sealing features, including, for example, aknife-edge and pressure seal as shown in FIG. 10.

The annular insert device 1300 may contain energization elements,conductive traces 1330, 1340, 1360, and 1370 and integrated circuits1392, or other electronic elements. In some embodiments, theseComponents 1392 may reside in a sealed cavity surrounding saidComponent. Components may be treated with encapsulating agents tosurround and seal the Components to the Front Curve Piece 1320 or BackCurve Piece 1325, before any combination of the two pieces is made toform an annular insert device 1300.

FIG. 14 illustrates how three pieces that when assembled may form anannular Multi-Piece Insert 1400. An annular Front Curve Piece 1430 mayinclude, for example, electrically conductive traces 1440 and integratedcircuits 1450. The Back Curve Pieces 1410 and 1420 may be individualportions of an annular insert device 1400. The Front Curve Piece 1430and Back Curve Pieces 1410 and 1420 may be combined to form a fullannular device 1400. In other embodiments, the two Back Curve Pieces1410 and 1420 may be combined to complete less than the full shape ofthe Front Curve Piece 1430. In FIG. 14, the Front Curve Piece 1430 isillustrated as a single piece and the Back Curve Pieces 1410 and 1420are illustrated as partial pieces, though the reverse may apply in otherembodiments.

In assembling the pieces of the annular insert device 1400, it may beapparent that the pieces 1430, 1410, and 1420 may be assembled twopieces at a time or all three pieces together. The order of assemblingthe pieces may vary in some embodiments. As an example, the Front CurvePiece 1430 may have electrical traces 1440 attached to an integratedcircuit 1450. Using a method as demonstrated in FIG. 10 at 1001 to 1004,the Back Curve Piece 1420 and the Front Curve Piece 1430 may be combinedand sealed by one of the various discussed embodiments resulting in afirst cavity 1425 that may be able to house the integrated circuit 1450and the electrical traces 1440. In some embodiments, the periphery ofthe combined Front Curve Piece 1430 and the Back Curve Piece 1420 maycontain a sensor 1490.

The newly formed insert pieces 1430, 1410, and 1420 may now haveenergization elements applied upon the conductive traces that resideoutside the cavity region 1425 but upon the insert surface. The BackCurve Piece 1410 may be combined with the Front Curve Piece 1430 to seala second cavity region 1415. The relative order of these steps isexemplary and a different order is well within the scope of theinventive art, as well as the extension of the concept to differentnumbers of insert pieces.

Methods for Annular Insert-Based Ophthalmic Lenses

The following method steps are provided as examples of processes thatmay be implemented according to some aspects of the present invention.It should be understood that the order in which the method steps arepresented is not meant to be limiting and other orders may be used toimplement the invention. In addition, not all of the steps are requiredto implement the present invention and additional steps may be includedin various embodiments of the present invention. It may be obvious toone skilled in the art that additional embodiments may be practical, andsuch methods are well within the scope of the claims.

Referring now to FIG. 15, a flowchart illustrates exemplary steps thatmay be used to implement the present invention. At 1501, at least aportion of an annular Front Curve Piece, such as, for example, thatpiece 1320 shown in FIG. 13, is formed, and at 1502 at least a portionof an annular Back Curve Piece, such as, for example, the piece 1325shown in FIG. 13, is formed. These formation steps at 1501 and 1502 maybe performed in either order or simultaneously. In other alternativeembodiments, the formation steps at 1501 and 1502 may result in partialannular pieces, such as, for example, the Back Curve Pieces 1410 and1420 in FIG. 14. In some embodiments, the formation steps at 1501 and1502 may result in pieces of varying portions of an annular shapewherein the Front Curve Pieces, such as, for example, said piece 1430 inFIG. 14, are not of equivalent annular portions to the Back CurvePieces, such as, for example, said pieces 1410 and 1420 in FIG. 14.

At 1503, a conductive material may be applied to either or both theannular Front Curve Piece of the insert or the annular Back Curve Pieceof the insert. At 1504, a sensing feature may be placed along theperiphery of an annular Front Curve Piece or, alternatively, along theperiphery of a sealing feature on a Front Curve Piece, such as, forexample, the annular Front Curve Piece 1320 or the sealing feature 1391in FIG. 13. In some specific embodiments, at 1505, a medicament pump andreservoir may be placed along the periphery of an annular Front CurvePiece or, alternatively, along the periphery of a sealing feature on aFront Curve Piece, such as, for example, the annular Front Curve Piece1320 or the sealing feature 1391 in FIG. 13.

At 1507, an adhesive or sealing material may be applied to either orboth of the annular Front Curve Piece and the annular Back Curve Piece.In some embodiments, the application of this material may involve theplacement of a preformed piece upon one or both of the insert pieces. Insome additional embodiments, there may be more than one of either orboth an annular Front Curve Piece and an annular Back Curve Piece, andthose pieces may combine to create less than a completed annularportion. In these embodiments, the step at 1507 would be repeated untilall applicable pieces of the ophthalmic insert are combined into aninsert.

At 1508, a reactive monomer mix can be deposited between a first Moldpart and a second Mold part or onto a surface of either the first or thesecond Mold part that will be between the two parts as a result ofsubsequent processing steps. At 1509, the combined insert is placed intoa cavity formed by the first Mold part and the second Mold part or ontoa surface that will be in a cavity formed by the first Mold part and thesecond Mold part at a later time. In some preferred embodiments, thecombined insert 104 of FIG. 1 is placed in the Mold part 101 and 102 ofFIG. 1 via mechanical placement. Mechanical placement can include, forexample, a robot or other automation, such as, for example, those knownin the industry to place surface mount Components. Human placement of aninsert 104 is also within the scope of the present invention.Accordingly, any mechanical placement is effective so long as it placesan insert 104 within a cast Mold part such that the polymerization of aReactive Mixture contained by the Mold part will include the insert in aresultant ophthalmic Lens. In some embodiments, a processor device,MEMS, NEMS, or other Component may also be mounted in or on the insertand be in electrical communication with an Energy Source.

At 1510, the first Mold part can be placed proximate to the second Moldpart to form a Lens-forming cavity with at least some of the reactivemonomer mix and the Energy Source in the cavity. At 1511, the ReactiveMonomer Mix within the cavity can be polymerized. Polymerization can beaccomplished, for example, via exposure to one or both of actinicradiation and heat. At 1512, the Lens is removed from the Mold parts.

Although the invention may be used to provide hard or soft contactLenses made of any known Lens material, or material suitable formanufacturing such Lenses, preferably, the Lenses of the invention aresoft contact Lenses having water contents of approximately 0 to 90percent. More preferably, the Lenses are made of monomers containingeither or both hydroxy groups and carboxyl groups, or be made fromsilicone-containing polymers, such as siloxanes, hydrogels, siliconehydrogels, and combinations thereof. Material useful for forming theLenses of the invention may be made by reacting blends of macromers,monomers, and combinations thereof along with additives such aspolymerization initiators. Suitable materials include, withoutlimitation, silicone hydrogels made from silicone macromers andhydrophilic monomers.

CONCLUSION

The present invention, as described above and as further defined by theclaims below, provides methods for sealing and encapsulating Componentswithin and upon Multi-Piece Inserts and apparatus for implementing suchmethods, as well as ophthalmic Lenses formed with the Multi-PieceInserts.

The invention claimed is:
 1. A method of forming an annular multi-pieceinsert for an ophthalmic lens, the method comprising: forming a firstinsert back curve piece into at least a portion of a first annular shapehaving an inner peripheral edge and an outer peripheral edge; forming afirst insert front curve piece into at least a portion of a secondannular shape having an inner peripheral edge and an outer peripheraledge; depositing a conductive material onto one or both of the firstinsert front curve piece and first insert back curve pieces; attachingan electronic component to one or both of the first insert front curvepiece and first insert back curve pieces, wherein the attachment is madeat least in part to the conductive material; placing a first material,upon a surface of one or both of the first insert front curve piece andfirst insert back curve pieces; and combining the first insert backcurve piece with the first insert front curve piece to form a firstannular ophthalmic insert piece such that the inner peripheral edge ofthe front curve piece and the inner peripheral edge of the back curvepiece overlap to form an inner edge seal and the outer peripheral edgeof the front curve piece and the outer peripheral edge of the back curvepiece overlap to form an outer edge seal, wherein the combining causesthe first material to seal a first cavity interior to the combination ofthe first back curve piece and the first front curve piece.
 2. Themethod of claim 1, additionally comprising the steps of: forming atleast a second insert back curve piece, into a portion of said firstannular shape; placing a second material to form a second seal uponeither or both of the first insert front curve piece and second insertback curve pieces; and combining the first annular ophthalmic insertpiece with the second insert back curve piece to form a second annularophthalmic insert piece, wherein the combining causes the secondmaterial to seal a second cavity interior to the combination of thefirst ophthalmic insert piece and the second insert back curve piece. 3.The method of claim 1, wherein the first cavity contains the electroniccomponent.
 4. The method of claim 1, wherein the electronic component isexterior to the sealed first cavity.
 5. The method of claim 1,additionally comprising: placing a first sensing element adjacent to theinner edge seal, wherein the first sensing element is in electricalcommunication with the electronic component.
 6. The method of claim 5,additionally comprising: placing a medicament pump and reservoir alongthe adjacent to the inner edge seal.
 7. The method of claim 1,additionally comprising: placing a second sensing element upon a surfaceof the first insert front curve piece remote from some inner edge seal,wherein the second sensing element is in electrical communication withthe electronic component.
 8. The method of claim 1, wherein the firstsealing material comprises a first preformed shape, and wherein one orboth of the first annular shape and second annular shape accommodatesthe first preformed shape.
 9. The method of claim 1, wherein the firstmaterial creates the first seal through mechanical contact between thefirst material and a first portion of one or both of the first insertback curve piece and the first insert front curve piece.
 10. The methodof claim 9, further comprising: placing a second material on one or bothof the first insert front curve piece and the first insert back curvepiece that forms a second material adhesive seal between the firstinsert front curve piece and first insert back curve piece thatmaintains physical contact of one or both of the first insert back curvepiece and the first insert front curve piece to the first material. 11.The method of claim 9, wherein the first material further comprises afirst self-locking feature capable of maintaining a physical contact ofone or both of the first insert back curve piece and the first insertfront curve piece to the first material.
 12. The method of claim 11,wherein the first self-locking feature fixedly holds the first insertback curve piece in a relative position to the first insert front curvepiece.
 13. The method of claim 2, wherein the first insert back curvepiece includes a first self-locking feature; the second insert backcurve piece includes a second self-locking feature, wherein the secondself-locking feature is capable of interlocking with the firstself-locking feature.
 14. The method of claim 1, additionallycomprising: applying a sealing agent to at least a portion of theelectronic component after attachment of the electronic component ismade to the conductive material.
 15. The method of claim 1, additionallycomprising: applying a sealing agent to at least a portion of theconductive material.
 16. The method of claim 2, additionally comprising:applying a sealing agent to at least a portion of the conductivematerial.
 17. The method of claim 1, additionally comprising: depositinga reactive mixture on a surface of a first mold part; positioning thefirst annular ophthalmic insert piece in contact with the reactivemixture; positioning a second mold part proximate to the first mold partto form a lens cavity, wherein the reactive mixture and the firstophthalmic insert are located within the lens cavity; polymerizing thereactive mixture to form an ophthalmic lens; and removing the ophthalmiclens from the mold parts.
 18. The method of claim 2, additionallycomprising: depositing a reactive mixture on a surface of a first moldpart; positioning the second annular ophthalmic insert piece in contactwith the reactive mixture; positioning the second mold part proximate tothe first mold part to form the lens cavity, wherein the reactivemixture and the second ophthalmic insert are located within the cavity;polymerizing the reactive mixture to form the ophthalmic lens; andremoving the ophthalmic lens from the mold parts.
 19. The method ofclaim 1, additionally comprising: adding a colorant layer to theperiphery of the insert.
 20. The method of claim 2, wherein the secondophthalmic insert includes an energization component, in electricalcommunication with the electronic component.
 21. The method of claim 1,wherein the first insert back curve piece includes a first sealingfeature adjacent the inner peripheral edge and a second sealing featureadjacent the outer peripheral edge.
 22. The method of claim 21, whereinsaid sealing features comprise raised annular projections formed in thefirst insert back curve piece.
 23. The method of claim 22, wherein saidfirst sealing feature and said inner peripheral edge of said firstinsert back curve piece form a first groove, said second sealing featureand said outer peripheral edge of said insert back curve piece form asecond groove and said first material is disposed within said grooves.24. The method of claim 23, wherein said first insert front curve pieceincludes raised annular projections adjacent its inner peripheral edgeand outer peripheral edge which engage the first material within thegrooves in the first insert back curve piece.